NCT02572908

Brief Summary

This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

October 5, 2015

Last Update Submit

August 4, 2016

Conditions

Irritable Bowel SyndromeWheat Sensitivity

Keywords

wheat, IBS, gluten, ATI

Outcome Measures

Primary Outcomes (1)

  • Subjective symptoms using visual analog scale (VAS) daily

    Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day

    7 days

Study Arms (3)

Fermented wheat bread for 7 days

ACTIVE COMPARATOR

Long sourdough fermentation

Other: Sourdough wheat breadOther: Gluten-free diet

Yeast baked wheat bread for 7 days

PLACEBO COMPARATOR

Regular toast bread

Other: Regular yeast baked toast breadOther: Gluten-free diet

Run-in

OTHER

Gluten-free diet for 7 days before entering either bread period

Other: Gluten-free diet

Interventions

Sourdough wheat breadOTHER
Fermented wheat bread for 7 days
Regular yeast baked toast breadOTHER
Yeast baked wheat bread for 7 days
Gluten-free dietOTHER

Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains

Fermented wheat bread for 7 daysRun-inYeast baked wheat bread for 7 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IBS \& subjective sensitivity to wheat

You may not qualify if:

  • celiac disease, pregnancy, lactation, IBD, major GI operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aava Medical Centre

Helsinki, Helsinki, 00100, Finland

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeIchthyosis Bullosa of Siemens

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 9, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

FI(1)